19 July 2019 - EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency. 

Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, safe and effective medicines to patients. At the same time, EMA recognises the importance of guaranteeing the independence of the medicine assessment which takes place at a later stage.

Supporting better designed studies means that patients will not be deprived of a beneficial medicine simply because poorly designed trials failed to demonstrate that the medicine works and is safe. By supporting the conduct of well-designed studies, scientific advice protects patients from taking part in studies that are sub-standard or will not produce useful evidence for a marketing authorisation.

Read EMA press release